10.02.2012 12:29:39
The US Food and Drug Administration is getting ready to review generic biotech drugs for the first time.
In advance of this, it released on 10 February 2012 guidelines under which the review process will be carried out. For consumers, the move represents the chance to obtain these hi-tech drugs - which presently command high prices - much more cheaply as so-called ‘biosimilars'.
The 2010 Patient Protection and Affordable Care Act featured one section calling for a biosimilar drug approval channel to open up but stated the FDA should be responsible for its content.
Draft Biotech Drug Guidelines
The draft biotech drug approval guidelines now release represent the administration's response to this call and they cover several areas. These include ‘Scientific Considerations', which supplies information to help generic biotech drug manufacturers prove that their products resemble those on which they're based. Also focused on are ‘Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product'.
"When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process", Janet Woodcock from the administration's Center for Drug Evaluation and Research explained in a statement. She added: "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
Generic Biotech Drug Approval
Responding to the news of these generic biotech drug approval guidelines' release, manufacturers expressed content and a statement issued by GPhA - the Generic Pharmaceutical Association sums up their feelings.
"GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients", the organisation said.
According to IMS Health, the worldwide biosimilars market has the potential to reach $25bn in value by 2020, thereby occupying a 10 per cent share of the overall biotech drugs market.
From here, the FDA's guidelines will be open for 60 days consultation, then firmed-up before being re-released in final form.
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2012-02-10 10:23:41
Scientists, long searching for a cure for Alzheimer’s, a reporting a dramatic breakthrough: a drug that quickly reverses the pathological, cognitive and memory deficits in mice afflicted with the disease. The results point to the significant potential that the drug, bexarotene, could help the more than 5 million Americans suffering from the brain disease. However, they cautioned that the study was only used in mice, and that the research needs much more work to determine if the medication will show positive results in humans. Current drugs on the market only slow the progression of Alzheimer’s disease. But the neuroscientists at Case Western Reserve University School of Medicine, hope bexarotene, or a similar variation, will someday work in humans as well. The researchers, reporting in the US journal Science, said mice treated with the drug became rapidly smarter and the plaque in their brains that was causing Alzheimer’s started to disappear within hours. “We were shocked and amazed,” lead author Gary Landreth, a professor in the Department of Neurosciences at Case Western Reserve University School of Medicine in Ohio, told the AFP news agency. “Things like this had never, ever been seen before.” Landreth, explaining how bexarotene works, said levels of the protein Apolipoprotein E (ApoE are boosted which then helps clear amyloid plaque buildup in the brain, a major trait of Alzheimer’s. “Think of this as a garbage disposal,” said Landreth. “When we are young and healthy, all of us can basically get rid of this (amyloid and degrade it and grind it into small bits and it gets cleared.” But many of us are “unable to do this efficiently as we age. And this is associated with mental decline or cognitive impairment,” he said. Within six hours of receiving the drug, soluble amyloid levels in the mice fell 25 percent, ultimately reaching a 75 percent drop over time. The authors found that the mice, soon after taking the drug, began performing better in tests, showing they were able to remember things again, were more social and were able to smell again, a sense that is commonly lost in Alzheimer’s patients. Within 72 hours after the treatments, the mice were able to associate paper with nests and began building again -- another function lost in mice with Alzheimer’s. “This is an unprecedented finding. Previously, the best existing treatment for Alzheimer's disease in mice required several months to reduce plaque in the brain,” said study coauthor Paige Cramer, a PhD candidate at the university’s School of Medicine. “This is a particularly exciting and rewarding study because of the new science we have discovered and the potential promise of a therapy for Alzheimer’s disease,” added Landreth. “We need to be clear; the drug works quite well in mouse models of the disease. Our next objective is to ascertain if it acts similarly in humans.” If bexarotene is to work in humans, it might be best targeted at people in the early stages of the disease, because, as seen in the nest building behavior of mice with Alzheimer’s, the nests are nowhere near as good as those built by healthy mice, according to the team. The team said clinical trials for humans are currently being designed and should produce early results in the coming year. The US Food and Drug Administration (FDA had previously approved bexarotene for the treatment of a rare form of cancer -- cutaneous T-cell lymphoma -- more than a decade ago. It was initially made by US-based Ligand Pharmaceuticals under the brand name Targretin. Eisai Pharmaceutical from Japan bought the rights for Targretin in 2006 and it is now available through Eisai in 26 countries in Europe, North America and South America. Scott Turner, director of the Georgetown University Medical Center's Memory Disorders Program, who was not involved in the research, told Kerry Sheridan of AFP that he was excited by the findings. “This is a brand new way to move forward in human trials of Alzheimer's disease and it works great with mice.” Turner, an expert in Alzheimer’s disease, cautioned, however, that more research was needed to see if the same results can be seen in humans. “One obstacle is that the mice may not be a good model of Alzheimer’s disease. We have so many things that work in mice and we try them in humans and they just completely fail,” he said. The FDA gives bexarotene a good safety profile, although women who are pregnant or may become pregnant are urged not to use it because of possible fetal defects. Typical side effects of the drug include diarrhea, dizziness, nausea, dry skin and trouble sleeping. Since bexarotene is prescribed for cancer patients, there are no anecdotal reports of improved memory in humans, according to Landreth. This may be because most cancer patients do not live long enough to reach the age of when Alzheimer’s usually strikes. Alzheimer’s and other forms of dementia affect more than 35 million people worldwide, with cases expected to double by 2030, according to Alzheimer's Disease International which puts the annual global costs of the disease at $604 billion. Landreth said funding and support for the research came with help from the Blanchette Hooker Rockefeller Foundation, the Thome Foundation, and the National Institutes of Health. --- On the Net:
10.02.2012 6:55:00
An ongoing legal case between GlaxoSmithKline and courts in Argentina has drawn attention to possible procedural problems in trials done in developing nations. Natalia Fuertes reports.
After GlaxoSmithKline (GSK was fined US$92 000 by Argentinian courts for administrative irregularities in a vaccine trial, observers have questioned whether trials are done under the same strict principles all over the world.
On Dec 28, 2011, Marcelo Aguinsky, a judge in the province of Mendoza, found GSK guilty of irregularities in obtaining informed consent in a trial assessing the efficacy and safety of Synflorix—a vaccine against Streptococcus pneumoniae and acute otitis media caused by non-typeable Haemophilus influenzae. Aguinsky fined the drug company and the two main investigators, Miguel Tregnaghi and Hector Abate, a total of AR$1 million. GSK is currently appealing the decision. “GSK conducts clinical trials to the same high standards, irrespective of where in the world they are run”, the company said in a statement.
The COMPAS trial was done between 2007 and 2008 in rural areas of three provinces in the east and north of Argentina—Mendoza, Santiago del Estero, and San Juan. It involved around 400 health professionals and was originally intended to recruit 17 000 children.
Problems in the GSK trial first came to light in 2007, when paediatrician Ana Marchese reported possible irregularities to FeSProSa (Syndicate Federation of Argentinian Health Professionals after speaking to the trial participants' families. FeSProSa investigated the accusations and filed a report to the National Administration of Drugs, Food and Medical Technology (ANMAT in December, 2007, declaring problems surrounding informed consent. GSK stated that it was the company that had identified the irregularities through self-monitoring and reported them straight to ANMAT.
ANMAT undertook an inspection of the procedures and consent forms and found that in some of them, there was reason to believe that the parents of the participants did not fully understand what they were signing and the witnesses were not impartial. Due to these irregularities, the recruitment process was stopped in August, 2008. Roberto Lede, director of Planning and Institutional Relationships of ANMAT, states that “the intervention of the ANMAT was very opportune. The recruitment was stopped in the way it was being carried out and resumed with intensive control. It should be noted that the irregularities only affected less than 1% of the subjects.”
14 infants who were taking part in the COMPAS trial died during it. However, because they were in the placebo group, GSK and ANMAT agreed that the trial could continue. COMPAS ended successfully in 2008, with only 18% fewer subjects than originally intended, and Synflorix was approved by ANMAT.
However, as the problem regarding invalidity of some of the consent forms remained, ANMAT issued a fine to GSK and the local doctors in charge. While GSK are appealing the fine in Mendoza, in Santiago del Estero, their appeal to the Supreme Court was successful, and the ruling was dismissed. In San Juan, the local courts have yet to rule.
The ruling of the Argentinian courts marks a pivotal moment in the regulations of trials by local authorities. Luis Petri, a member of the Lower House in Mendoza presented a bill in early January, 2012, to ban clinical trials in the province. “Children of Mendoza must not be used as guinea pigs by pharmaceutical companies to try their drugs or vaccines, regardless of the consent of their parents”, he stated. The bill is still under consideration.
In 2007, about 200 trials were done in Argentina, but not all of them were officially registered. After the irregularities in the COMPAS trial were disclosed, the government decided to create a National Register of Trials. In November, 2008, ANMAT ordered drug companies throughout the country to include a warning sign in red capital letters on every consent form, clearly stating the experimental nature of the trial. However, ANMAT's Lede said that “there was no need to introduce any modifications to the law; the problem was not the law but the compliance with it”.
Brian Angus, director of the Wellcome Trust UK Centre for Clinical Tropical Medicine in Oxford, UK, states that “protection of volunteers for clinical trials is crucial. Especially overseas, where people sometimes do not have the level of education to understand the implications of a clinical trial, there is even greater need for the doctors to act in the patient's best interests. It is ultimately the doctor's responsibility. What would you do if somebody agrees to be part of a clinical trial but you do not think they really understand what it means? The answer is clear, you do not recruit them.”
GSK's fine is the largest Argentina has issued against a drug company. And while the case has led to legal changes in the country, it has also drawn attention to the need to improve ethical and procedural standards of trials done in developing regions of the world.
10.02.2012 23:30:14
UnitedHealth Group is pushing into managing pharmacy benefits, bucking a trend among U.S. health insurers and threatening the dominance of the three largest companies that help negotiate drug pricing.
10.02.2012 23:44:28
The stated mission of the Food and Drug Administration (FDA is to protect and promote public health through the regulation of everything from food products to pharmaceutical drugs. Based on the agency's actions (or perhaps their severe lack of real action however, it is quite apparent that this government organization has a blatant disregard for your health and is most certainly not in the business of 'promoting' health. Here are 4 ways in which the FDA has gone against public health and safety. 1. FDA Sits Back as You Consume Mercury in Your Food The FDA, despite having full access to the studies that were heavily publicized even on mainstream media websites, apparently feels that carcinogenic mercury tainting the food supply is nothing to worry about. Found to be present in over a third of 55 popular brand-name food and beverage products, research has shown that you are most likely consuming mercury if you consume processed food items or many beverage products. High-fructose corn syrup is a main carrier of the harmful element, which is especially concerning when you consider the fact that the average American consumed 37.8 pounds of high-fructose corn syrup in 2008! Despite experts speaking out and calling on the FDA to come to the aid of the public, the FDA still does nothing. "Mercury is toxic in all its forms. Given how much high-fructose corn syrup is consumed by children, it could be a significant additional source of mercury never before considered. We are calling for immediate changes by industry and the [U.S. Food and Drug Administration] to help stop this avoidable mercury contamination of the food supply," the Institute for Agriculture and Trade Policy's Dr. David Wallinga, a co-author of both studies, said in a prepared statement.
10.02.2012 6:50:00
The
Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up.
In a
letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define e-cigarettes as a tobacco product.
10.02.2012 23:30:14
A national coalition of pharmacists and pharmacy owners announced last week a public information campaign to expose the unjustifiably high prices of prescription drugs set by pharmacy benefit managers, the unregulated, multibillion dollar industry that controls prescription health plans for more than 200 million Americans.
10.02.2012 23:30:14
It's been a little over two months since pharmacy chain Walgreens announced it would be leaving Express Scripts' pharmacy provider network. Kermit Crawford, president of Walgreens' pharmacy, health and wellness business, sat down with EBN recently to discuss his company's position.
11.02.2012 3:08:00
David Pilgrim, Professor of Mental Health Policy at the University of Central Lancashire, said: “It’s hard to avoid the conclusion that DSM-5 will help the interests of the drug companies and the wrong-headed belief of some mental health professionals.”
He said DSM-5, set for release in May next year, generates substantial income and reinforces the role of the American Psychiatric Association, as well as playing down “the complexity of people’s problems that are a mixture of psychological, social and biological factors”.
11.02.2012 2:59:48
U.S. health regulators issued recommendations to ensure the safe production of the blood-clot prevention drug heparin, four years after a contamination involving the widely used product set off concerns about the global pharmaceutical supply chain.
11.02.2012 1:35:24
Reuters - Health regulators issued recommendations to ensure the safe production of the blood-clot prevention drug heparin, four years after a contamination involving the widely used product set off concerns about the global pharmaceutical supply chain.
10.02.2012 23:30:14
Twenty-five percent of employers have little or no understanding of specialty pharmacy and 53% have only a moderate understanding of this challenging benefit according to a new survey released by the Midwest Business Group on Health.
10.02.2012 23:30:14
Catalyst Health Solutions Inc said it will buy Walgreen Co's pharmacy benefits management unit for about $525 million in cash, a deal that might spur more consolidation before big generic drug launches that could boost the business.
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